Class II · Moderate risk Ongoing
Furosemide Tablets
Reason CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Furosemide 20 mg/mL svn Sol
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
What was recalled
Furosemide 20 mg/mL svn Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
- Recalling firm
- Western Drug
- Origin
- AZ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0405-2016
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Furosemide recalls
See all
Class II · Moderate risk Ongoing
Furosemide Tablets
Reason Presence of Foreign Substance
Class I · High risk Terminated
Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection
Reason Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide.
Class II · Moderate risk Terminated
Furosemide Tablets USP
Reason Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
Class III · Low risk Terminated
FUROSEMIDE Tablets USP
Reason CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
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